ROWASA Drug Patent Profile

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When do Rowasa patents expire, and when can generic versions of Rowasa launch?

Rowasa is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs.

The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rowasa

A generic version of ROWASA was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

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Summary for ROWASA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	3
Patent Applications:	4,710
Drug Prices:	Drug price information for ROWASA
What excipients (inactive ingredients) are in ROWASA?	ROWASA excipients list
DailyMed Link:	ROWASA at DailyMed

Drug patent expirations by year for ROWASA

Recent Clinical Trials for ROWASA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dayanand Medical College and Hospital	Phase 3
Colitis & Crohn's Foundation (India)	Phase 3
Altheus Therapeutics, Inc.	Phase 1

See all ROWASA clinical trials

Pharmacology for ROWASA

Drug Class	Aminosalicylate

US Patents and Regulatory Information for ROWASA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meda Pharms	ROWASA	mesalamine	SUPPOSITORY;RECTAL	019919-001	Dec 18, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ROWASA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ROWASA

See the table below for patents covering ROWASA around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	2107870		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008094618		⤷ Sign Up
Spain	2026179		⤷ Sign Up
New Zealand	578674	REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD)	⤷ Sign Up
Canada	2677095	LAVEMENT AMELIORE A EFFET IRRITANT REDUIT DESTINE AU TRAITEMENT D'UNE AFFECTION INTESTINALE INFLAMMATOIRE (IBD) (IMPROVED REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD))	⤷ Sign Up
Spain	2567068		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ROWASA

Recent Clinical Trials for ROWASA

Pharmacology for ROWASA

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